This invention relates to an apparatus for securing a catheter in position for insertion into a tubular body member or structure.
The invention may best be described by reference throughout to the procedure and use of the device in reference to the operative procedure of intraoperative cholangiography. Cholangiography is a procedure to determine the presence or absence of gall stones in the common bile duct. It is commonly required during gall bladder surgery where positive indications of gall stones are found and where it becomes necessary to determine the presence of or absence of gall stones in the common bile duct during the course of cholecystectomy.
The overall operative technique and its requirements are disclosed in any standard reference such as the "Textbook of Surgery", Sabiston, ed. or "Principals of Surgery" by Schwartz, et al. Only so much of the related procedure as is necessary to elucidate and illustrate the design and use of the inventive clamp will be discussed here.
In order to insure that no gall stones remain in the common bile duct, after gall bladder excision, it is now considered desirable to perform cholangiography to determine the absence of such residual gall stones should there be any evidence during gall bladder surgery that stones have been formed; it has been estimated that in 85% of gall bladder surgery cases, cholangiography is suggested during the operative procedure.
The technique requires the placing of a catheter into the cystic duct, through a cut made in the cystic duct, and the injection, through the catheter, of radiographically opaque material. An x-ray is then obtained and examined for presence of gall stones. Upon completion of the procedure, the tube is removed and the stump of the cystic duct is tied or clipped closed.
The entire procedure is performed during the surgical operation, in order to determine the necessity of proceeding further for the removal of common bile duct stones, and thus, for the safety of the patient, must be performed accurately, expeditiously and quickly. Temporarily securing the catheter in the stump of the cystic duct has been a continuing problem. The catheter must be secured well enough to prevent leaks during dye injection, and the catheter must remain in place despite manipulation, yet the cathether must be easily removable after the x-ray is taken. Several methods have been devised, commonly all involving some form of temporary surgical tie around the cystic duct in an attempt to secure it to the catheter tip; all such techniques had attendant problems of forming a satisfactory seal to prevent the leakage of the dye without collapsing the catheter from overtightening, or of preventing the slippage of the catheter, and so as to permit rapid performance of the technique with relatively little additional trauma or strain upon the operative patient. Moreover, the use of a surgical tie is removed by cutting, and this introduces attendant dangers of laceration and injury.